Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
NCT ID:
NCT02684058
Description:
Deaths in the post treatment follow-up period are not considered Adverse Events. The total number at risk in the post treatment includes patients that entered the post treatment follow-up period (post-treatment efficacy and/or survival follow-up). Analysis performed in the safety set including participants who received at least one dose of study treatment. None of the patients who crossed-over were included in the crossover post-treatment efficacy/survival follow-up.
Frequency Threshold:
4.9999
Time Frame:
On-treatment AEs: from first dose to 30 days after last dose of treatment (or start of crossover treatment), up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment deaths: from 31 days post-treatment to end of study (or start of crossover treatment), up to 4.6 years (LGG) and 5.1 years (HGG).Crossover on-treatment: AEs from first dose to 30 days after last dose of crossover treatment, up to 4.2 years.
Study:
NCT02684058
Study Brief:
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| LGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) | Deaths collected in the post- treatment follow-up period for participants in the LGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period | 0 | None | 0 | 0 | 0 | 0 | View |
| HGG Cohort: Dabrafenib and Trametinib (On-treatment) | AEs collected during on-treatment period with dabrafenib and trametinib in the HGG cohort (up to 30 days post- treatment) | 6 | None | 28 | 41 | 41 | 41 | View |
| HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) | Deaths collected in the post- treatment follow-up period for participants in the HGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period | 11 | None | 0 | 0 | 0 | 0 | View |
| LGG Cohort: Dabrafenib and Trametinib (On-treatment) | AEs collected during on-treatment period with dabrafenib and trametinib in the LGG cohort (up to 30 days post- treatment) | 0 | None | 34 | 73 | 73 | 73 | View |
| LGG Cohort: Carboplatin and Vincristine (On-treatment) | AEs collected during on-treatment period with carboplatin and vincristine in the LGG cohort (up to 30 days post- treatment or start date of crossover treatment, whichever was earlier) | 0 | None | 14 | 33 | 33 | 33 | View |
| LGG Cohort: Carboplatin and Vincristine (Post-treatment Follow-up) | Deaths collected in the post- treatment follow-up period (starting from day 31 post- treatment) for participants in the LGG cohort treated with carboplatin and vincristine. No AEs were collected during this period | 0 | None | 0 | 0 | 0 | 0 | View |
| LGG Cohort: Carboplatin and Vincristine (Crossover Post-treatment Follow-up) | Deaths collected in the crossover post- treatment follow-up period (starting from day 31 post- crossover treatment) for participants in the LGG cohort treated with carboplatin and vincristine who crossed over to dabrafenib and trametinib. No AEs were collected during this period | 0 | None | 0 | 0 | 0 | 0 | View |
| LGG Cohort: Carboplatin and Vincristine (Crossover On-treatment) | AEs collected during crossover on-treatment period with dabrafenib and trametinib for participants in the LGG cohort randomized to carboplatin and vincristine who crossedover to dabrafenib and trametinib after disease progression (up to 30 days post- crossover treatment) | 1 | None | 4 | 12 | 11 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| Ventricular enlargement | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| Detachment of retinal pigment epithelium | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Bacterial sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Brain abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Encephalomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Toxic shock syndrome | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Viral myositis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Shunt malfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Tooth avulsion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Altered state of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Cerebral ventricle dilatation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Cerebrospinal fluid circulation disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Facial paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Intracranial pressure increased | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Ischaemic cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Migraine with aura | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Paresis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Partial seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| Renal colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| Uterine haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (24.0) | View |
| Apnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Erythema nodosum | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (24.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (24.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| Papilloedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Haematological infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Vulvitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Central nervous system lesion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Optic perineuritis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Tonsillar hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Blood bicarbonate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| SARS-CoV-2 test negative | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Cerebral salt-wasting syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Device malfunction | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (24.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| Intentional self-injury | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Erythema nodosum | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Hand dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Ingrowing nail | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Keratosis pilaris | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Panniculitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Papule | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Skin striae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (24.0) | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (24.0) | View |
| Growth hormone deficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (24.0) | View |
| Thyroid disorder | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (24.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Cyst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Hyperpyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Pulpitis dental | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Tinea manuum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.0) | View |
| Blood pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| SARS-CoV-2 test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Streptococcus test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (24.0) | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (24.0) | View |
| Immobilisation syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| Somatic symptom disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.0) | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (24.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Snoring | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Tonsillar hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Dyshidrotic eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Erythema multiforme | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Hyperkeratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (24.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (24.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| Aortic valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (24.0) | View |
| Eyelid ptosis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (24.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Angular cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Aphthous ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (24.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (24.0) | View |